Early in my career in Australia’s Flying Doctor Service, I had the privilege of providing emergency care to the rural poor. In many cases, I was able to give my patients innovative treatments that cured their ailments and improved their health and lives overall. The feelings I experienced from helping those vulnerable patients stays with me today and continues to drive me in my current role overseeing our global health portfolio of products and services for diseases of high public health impact and working with committed leaders advancing our technologies including those directed against HIV, tuberculosis, and Ebola.
Providing patients with effective treatments is the goal of every healthcare professional, scientific researcher, developer and manufacturer of new treatments and therapies. When those treatments and therapies don’t exist, there is nothing harder than looking into the eyes of your patient and their loved ones and telling them there are no options. It is their stories that compel us to do more to meet their needs by working together to bring forward new therapies.
The recent Ebola crisis and the rise in drug-resistant bacteria have forced our attention to the inadequacy of our therapeutic arsenals to address these major public health threats. Antibiotics are unique in that we want to preserve their effectiveness by promoting appropriate use, especially in a world where over-prescription of antibiotics is too high and has dangerous effects on public health. With millions of lives at risk, the absence of ready, proven therapeutic and other tools – despite the emergence of these threats years, even decades, ago — leaves the world defenseless to fight these potentially lethal diseases.
Yesterday, the White House recognized the desperate need to protect the public’s health against drug resistant bacteria by announcing a new executive order to accelerate the development of new antibiotics by 2020. In July, the UK government, claiming antimicrobial resistance poses a “catastrophic threat”, announced a review into why so few anti-microbial drugs have been introduced in recent years. The U.S. Congress and President Obama also recognized the importance of infusing new incentives into the development of needed antibiotic therapies, with the 2012 GAIN Act, an important first step toward a more comprehensive restructuring of the incentive model for antibiotics research and development (R&D).
However, current conditions demand even greater options and flexibility to stimulate research & development toward new antibiotics and adjacent technologies such as diagnostics.
Today, the innovation climate for investing in the research and development of antibiotics and other antimicrobial interventions remains suboptimal, even despite recent laudable efforts to improve it. One factor is the basic science associated with this field continues to prove exceedingly difficult, with high rates of failure. Another factor is that the current incentive structure for antibiotics has proven insufficient to stimulate the level of new antibiotic R&D investments so critically needed to strike back at drug-resistant infections.
In a congressional hearing held today to examine solutions to the current crisis, panelists including myself urged consideration of a special framework for innovation in antibiotics R&D sufficient to attract the world’s best and brightest to this great challenge. Based on ongoing engagement with a broad set of innovators, government agencies and a coalition of health care stakeholders including the Antimicrobial Innovation Alliance and the Infectious Diseases Society of America, we talked about the need for a broad set of highly attractive incentives to engage many biomedical innovator companies and academic researchers, large and small, in this work.
Incentives that could help promote investment in “socially desirable but unprofitable medicine” include: improving the reimbursement of novel antibiotic and antifungal products in the hospital setting; transferable market exclusivity vouchers awarded to certain antimicrobials products that can prolong exclusivity for other products; refundable tax credits for antimicrobial research and development costs; and allowing more rapid licensure of limited population products. A variety of such incentives can help offset the challenges involved with developing any innovative therapy, including the immense cost, risk, complexity and lengthy duration.
The benefit of a ‘package’ of incentives is it allows concepts to be tested and programs to be assessed and refined, to find answers to what will work – and how, when and where will it work best. It also offers individual innovators of different sizes and character the greatest potential and flexibility to address various issues facing different organizations and programs at different stages of antibiotic development.
Protecting the public’s health by developing new antibiotic treatments or vaccines is important now more than ever. We need to take action to stave off a global health crisis which, if left unchallenged, could see routine operations become deadly because of the risk of infection. Our focus must be fixed on the end goal, namely: more options for patients, sooner. To achieve this, we must foster more “shots on goal,” by galvanizing and mobilizing the larger innovator community to apply its time, talents and resources to the challenge of antibiotic resistance. Failure is not an option.
Adrian Thomas M.D. is Vice President, Global Market Access & Commercial Strategy Operations and Head, Global Public Health at Janssen, the pharmaceuticals companies of Johnson & Johnson. Dr. Thomas testified at the House Energy and Commerce Health Subcommittee hearing “Examining Ways to Combat Antibiotic Resistance and Foster New Drug Development,” on September 19. .content